Interview with David Steinhaus, VP of Cardiac Rhythm Disease Management at Medtronic

Interview with David Steinhaus, VP of Cardiac Rhythm Disease Management at Medtronic

Last week Medtronic announced that the FDA has given the company expanded indication for its portfolio of cardiac resynchronization therapy with defibrillator (CRT-D) devices to now treat mildly symptomatic, NYHA Class II heart failure patients. We had a chance to speak with Dr. David Steinhaus, M.D., Vice President and General Manager, Heart Failure, and Medical Director for the Cardiac Rhythm Disease Management business at Medtronic.

Ronney Shantouf, M.D., Medgadget: Can you explain the major difference between cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices vs. implantable cardioverter defibrillator (ICD) devices in terms what is implanted into the patient?

Dr. David Steinhaus: Both ICDs and CRT-Ds are small stopwatch-sized devices inserted directly under the skin in the upper chest. ICDs deliver lifesaving shocks or painless pacing to stop life-threatening fast or irregular heartbeats. CRT-D devices also stimulate the heart’s lower chambers to pump at the same time, and are used to help treat heart failure.

A standard ICD is fitted like a normal pacemaker, with either one or two leads in the right side of the heart. A CRT-D has a third and separate lead, which is threaded through the venous system and placed on the left ventricle.

medtronic crt d Interview with David Steinhaus, VP of Cardiac Rhythm Disease Management at MedtronicMedgadget: What is the mechanism by which CRT-D potentially improves symptoms, re-hospitalization, and mortality?

Dr. Steinhaus: Using tiny electrical impulses delivered to the heart muscle, CRT-D therapy resynchronizes the contraction of both ventricles, improving the heart’s pumping ability. The device also works as a defibrillator to terminate life-threatening ventricular arrhythmias.

NYHA Class II heart failure patients were previously indicated for an ICD, which protects them from sudden cardiac arrest (SCA), but doesn’t address their heart failure status. They can now benefit from CRT therapy, which has been proven (via REVERSE and RAFT) to reduce the time to first heart failure hospitalization, and a lower risk of death (above and beyond the benefits of an ICD). So essentially, CRT helps slow the progression of heart failure and improves heart function. This indication expansion enables us to treat these patients with CRT before their heart failure symptoms start seriously eroding their quality of life. As such, we view this expanded indication as having a significant benefit for heart failure patients.

Medgadget: Currently what companies have FDA approval for placing a CRT-D device in NYHA Class II heart failure patients (those with mild symptoms) who meet criteria?

Dr. Steinhaus: Boston Scientific is the only other company that has received FDA approval for its CRT-D devices to include certain mildly symptomatic heart failure patients. This approval was based on the MADIT CRT trial it sponsored.

In December 2011, an FDA advisory panel voted to recommend that indications (labeling) for Medtronic CRT-D devices also be expanded to include certain mildly symptomatic heart failure patients. The Panel based its decision on the strength of the REVERSE and RAFT clinical trials, which showed a significant reduction in mortality over more than 5 years (RAFT) as well as significant reduction in time to first heart failure hospitalization (both REVERSE and RAFT).

Medgadget: Do you think it’s possible the guidelines will be expanded to include NYHA Class I Heart Failure patients?

Dr. Steinhaus: Not at this time. No NYHA I patients were enrolled in RAFT and only 18 percent of REVERSE patients were NYHA I; MADIT CRT also only included a small number of Class I patients. The medical societies typically rely on a multiple trials, with significant numbers of treated patients, in order to revise guidelines. It’s unlikely based on the small numbers of NYHA Class I patients in these trials that the guidelines would be adjusted to include them as candidates for CRT.

Medgadget: How does the expansion of implanting ICDs to now CRT-D devices in NYHA Class II heart failure patients affect health care costs?

Dr. Steinhaus: Cost-effectiveness data from the RAFT trial, a landmark clinical trial that served (along with REVERSE) as the basis for this approval, will be presented at the Heart Rhythm Society congress in Boston next month. Additionally, data has previously been presented reinforcing the cost-effectiveness of CRT based on the Medtronic-supported REVERSE and CARE-HF trials.

Medgadget: Where do you see the future technology headed for chronic heart failure patients and the specific role devices will play?

Dr. Steinhaus: Heart failure is a complex disease affecting millions of patients and consuming large health care resources. Heart failure is also responsible for significant mortality and decreased quality of life. Future technologies may include device therapy that modulates the autonomic nervous system—a key element in heart failure progression. Devices may also improve management of these patients by improved monitoring of important physiologic parameters. Ultimately sensors may be combined with drug delivery or other device therapy to create closed loop systems.

This information is intended for media professionals and investors

News Release

Medtronic Media Contacts:

Kathleen Janasz, Public Relations, 763-526-3676

Jeff Warren, Investor Relations, 763-505-2696

Medtronic Receives FDA Approval to Treat Mildly Symptomatic Heart Failure Patients Through Expanded Indication for CRT-D

Pivotal REVERSE & Landmark RAFT Clinical Trials Demonstrate Reduction in Mortality and Heart Failure Hospitalization Rates in New Patient Population

MINNEAPOLIS – April 10, 2012 – Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for its cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices. With today’s approval, this advanced therapy can now be used earlier, in a mildly symptomatic heart failure patient population, potentially improving survival, reducing hospitalizations, and preventing disease progression.

The expanded indication includes New York Heart Association (NYHA) Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than or equal to 130 milliseconds. Nearly 200,000 Americans are considered NYHA Class II, with another 620,000 people worldwide fitting this designation. Medtronic CRT-D devices were previously indicated to treat certain patients with moderate-to-severe heart failure (NYHA Class III and IV), and have safely and effectively been used in these patients for more than a decade.

The FDA’s decision for the expanded indication rests on data from the pivotal REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) and landmark RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) clinical trials, which showed that CRT-D can benefit mildly symptomatic heart failure patients by reducing mortality and heart failure hospitalization rates.

“The RAFT and REVERSE study findings provide strong clinical evidence validating the safety, efficacy and lifesaving benefits of CRT-D for treating systolic heart failure patients with milder symptoms,” said Michael R. Gold, M.D., Ph.D., REVERSE study investigator and steering committee member, Michael E. Assay professor of medicine and director of cardiology at the Medical University of South Carolina. “This expanded indication fulfills an unmet need by treating these patients in the earlier stages of heart failure, before their symptoms more significantly impact their quality of life.”

While certain NYHA Class II patients are already indicated for an implantable cardioverter defibrillator (ICD) to protect them from sudden cardiac arrest (SCA), they are still vulnerable to experiencing an exacerbation of their heart failure. In fact, SCA is responsible for more than 60 percent of deaths among patients with mild-to-moderate heart failure. However, a growing body of clinical research suggests that earlier intervention with CRT-D can decrease the risk of morbidity and mortality in this mildly symptomatic patient population. CRT-D therapy works by resynchronizing the contractions of both ventricles by sending tiny electrical impulses to the heart muscles, which improves the heart’s blood-pumping ability. The device also has defibrillation capability, allowing for termination of life-threatening ventricular arrhythmias.

“Medtronic is pleased with the FDA’s decision to expand the use of the company’s innovative portfolio of CRT-D devices to treat thousands of patients with mildly symptomatic, Class II heart failure,” said David Steinhaus, M.D., Vice President and General Manager, Heart Failure, and Medical Director for the Cardiac Rhythm Disease Management business. “We are fully committed to enhancing patient outcomes through our extensive portfolio of advanced medical devices that have been proven safe, effective and efficient in treating heart failure patients across the continuum of care.”

The company will be embarking on a post-approval study to further substantiate the clinical benefits of CRT-D treatment in the Class II heart failure patient population. To date, Medtronic has supported eight major heart failure trials that have contributed to the continued development and broadening of evidence-based treatment guidelines.

About the RAFT Trial

Findings from the landmark RAFT clinical trial, published in the New England Journal of Medicine, showed that CRT-D significantly reduced mortality for mildly symptomatic heart failure patients (NYHA Class II) by 29 percent when compared to patients treated with guideline-recommended implantable ICDs and medical therapy (p=0.006; HR=0.71). The study also demonstrated a significant reduction (27 percent) in combined mortality and heart failure hospitalizations for this population (p=0.001; HR=0.73), consistent with previously published studies. All patients were followed for at least 18 months, and had an average follow-up of 40 months, making it the longest follow-up and largest patient months-of-experience of any study of CRT therapy.

About the REVERSE Trial

With 610 patients studied, REVERSE was the first large-scale, global, randomized, double-blind trial to demonstrate the impact of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms. All randomized subjects received a score of improved, unchanged or worsened, utilizing the Clinical Composite Response. For the pre-specified primary endpoint, the results showed that 21 percent of subjects without CRT worsened, compared to 16 percent with CRT (p=0.10); however, post-hoc analyses demonstrated that collectively comparing all the classifications of improved, unchanged or worsened was significant (p=0.004). Importantly, more patients in the trial improved with CRT than without (54 percent vs. 40 percent, respectively). Additionally, the analysis of pre-specified secondary endpoints in the REVERSE trial showed that CRT leads to improvement in both cardiac structure and function as measured by echocardiography, meaning the heart size improves and beats more effectively. CRT also delayed the time to first heart failure hospitalization in this patient group and reduced heart failure hospitalization or all-cause death by 51 percent (p=0.004, post-hoc).

About Medtronic

Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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